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Completed Studies

SPS3: Secondary Prevention of Small Subcortical Strokes

Sponsor: NIH
Investigators: Carlos Kase MD (principal), Viken Babikian MD, Jose Romero MD

N Engl J Med 2012; 367:817-825 August 30, 2012
SPS3 was a double-blind, multicenter trial involving 3020 patients with recent symptomatic lacunar infarcts identified by magnetic resonance imaging. Patients were randomly assigned to receive 75 mg of clopidogrel or placebo daily; patients in both groups received 325 mg of aspirin daily. The primary outcome was any recurrent stroke, including ischemic stroke and intracranial hemorrhage. In conclusion, in this clinical trial of clopidogrel and aspirin, as compared with aspirin alone, in patients with a recent lacunar stroke identified on MRI, it was found that the anticipated increase in the risk of major hemorrhage with dual antiplatelet therapy was not offset by a reduction in the risk of stroke recurrence, and there was an unexpected increase in mortality. Additional results from the component of the SPS3 trial involving blood pressure control are anticipated in 2012.

The Lancet, Volume 382, Issue 9891, Pages 507 - 515, 10 August 2013
Although the reduction in stroke was not significant, our results support that in patients with recent lacunar stroke, the use of a systolic-blood-pressure target of less than 130 mm Hg is likely to be beneficial.


TRA 2P – TIMI 50: Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Atherosclerosis

Sponsor: Schering Plough
Investigators: Carlos Kase MD (principal), Viken Babikian MD, Jose Romero MD

Trial results available here
This was a large clinical trial (with 26,449 patients) that evaluated whether the addition of SCH 530348 (Vorapaxar) to existing standard of care will yield additional benefit in prevention of heart attacks and strokes. In stable patients with a history of atherothrombosis, study results showed decreased deaths from cardiovascular disease, MI and stroke incidence and increased moderate and severe bleeding when added to standard of care. It appears to reduce recurrent atherothrombosis, caution is patient selection is needed due to increase bleeding.


PROFESS: Prevention Regimen For Effectively avoiding Second Strokes

Sponsor: Boehringer Ingelheim
Investigators: Carlos Kase MD, Viken Babikian MD, Jose Romero MD

PRoFESS Results Announced At XVII European Stroke Conference on Thursday 15 May 2008
The PRoFESS trial, a large clinical research study for secondary stroke prevention showed that the recurrent stroke event rates for Aggrenox and clopidogrel were similar. In further exploratory analysis of the main secondary endpoint of the composite of stroke, myocardial infarction or vascular death, AGGRENOX and clopidogrel showed similar outcomes (13.1% versus 13.1%). In PRoFESS, the AGGRENOX arm had a higher number of hemorrhagic strokes compared to clopidogrel (0.8% and 0.4%, respectively) while ischemic stroke recurrences were less frequent in the AGGRENOX arm compared to the clopidogrel arm (7.7% and 7.9%, respectively). A post-hoc analysis showed comparable numbers of death and disabling strokes and a similar neurological outcome as measured by the modified Rankin Scale at three months after the recurrent stroke and at the end of the PRoFESS trial between the two treatment arms.


ARUBA: A Randomized Multicenter Clinical Trial of Unruptured Brain AVMs

Sponsor: NIH
Investigator: Thanh Nguyen MD (principal), Alexander Norbash MD, Carlos Kase MD, Viken Babikian MD, Jose Romero MD

NINDS Statement: For release: Thursday, May 9, 2013
Upon the recommendation of the ARUBA Data and Safety Monitoring Board, the NINDS has stopped enrollment of patient volunteers into the trial. Under the experimental conditions in this trial, the interim analysis of data collected to date shows that medical management is superior to intervention in patients with unruptured brain arteriovenous malformations (AVMs).

ARUBA was a randomized, multi-center trial designed to evaluate whether symptomatic medical management improves long-term outcomes of patients with unruptured brain arteriovenous malformations compared to invasive treatment for the composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging); a secondary outcome is disability as measured by the Rankin Score. Invasive treatment could include endovascular procedures, neurosurgery, or radiotherapy alone or in combination. The intent was to randomize 400 participants and follow them for 5 to 10 years; however, because of the higher than expected event rate in the interventional arm compared with medical management, the DSMB recommended stopping enrollment while continuing to follow all participants to determine whether the difference in stroke and death in the two arms changes over time.


CONSCIOUS 3: Randomized trial of clazosentan in patients with aneurysmal subarachnoid hemorrhage undergoing endovascular coiling.

Sponsor: Actelion
Investigators: Thanh Nguyen MD (principal), Alexander Norbash MD, Carlos Kase MD, Viken Babikian MD, Jose Romero MD

Stroke. 2012 Jun;43(6):1463-9
Clazosentan, an endothelin receptor antagonist, has been shown to reduce vasospasm after aneurysmal subarachnoid hemorrhage (aSAH). CONSCIOUS-3 assessed whether clazosentan reduced vasospasm-related morbidity and all-cause mortality postaSAH secured by endovascular coiling. This double-blind, placebo-controlled, phase III trial randomized patients with aSAH secured by endovascular coiling to ≤ 14 days intravenous clazosentan (5 or 15 mg/h) or placebo. The primary composite end point (all-cause mortality; vasospasm-related new cerebral infarcts or delayed ischemic neurological deficits; rescue therapy for vasospasm) was evaluated 6 weeks postaSAH. The main secondary end point was dichotomized extended Glasgow Outcome Scale (week 12). In conclusion, Clazosentan significantly reduced postaSAH vasospasm-related morbidity/all-cause mortality; however, neither dose improved outcome (extended Glasgow Outcome Scale).


TEAM: A trial on unruptured intracranial aneurysms

Sponsor: CHUM
Investigators: Thanh Nguyen MD (principal), Alexander Norbash MD, Carlos Kase MD, Viken Babikian MD, Jose Romero MD

Published online Mar 4, 2011
The trial on endovascular management of unruptured intracranial aneurysms (TEAM), a prospective randomized trial comparing coiling and conservative management, initiated in September 2006, was stopped in June 2009 because of poor recruitment (80 patients). No final results available for review.


DIAS4: Desmoteplase in Acute Ischemic Stroke

Sponsor: Lundbeck
Investigators: Carlos Kase MD (principal), Thanh Nguyen MD, Viken Babikian MD, Jose Romero MD, Aleksandra Pikula MD

Summary: An ischemic stroke is caused by a blockage, called a clot, in an artery that supplies blood to the brain. This obstruction results in a loss of blood flow to the affected area of the brain. The goal of drug therapy used to treat this condition is to dissolve the clot, thereby opening the blood vessel and restoring blood flow to the brain. At this time, there are no FDA-approved medications to dissolve or remove the blood clot in patients that seek help greater than 4 ½ hours after the onset of their stroke symptoms. The purpose of this research study is to determine whether the investigational drug Desmoteplase is effective in the treatment of ischemic stroke when administered 4.5 to 9 hours after symptoms begin. Desmoteplase is being studied worldwide for its use in the treatment of individuals with stroke. This study examined the use of a synthetic drug derived from the saliva of vampire bats. The study examined whether this drug would extend the time window for treatment of acute ischemic strokes from three to nine hours after symptoms first appear, by dissolving the clot that caused the stroke.

Results pending


PREDICT: Predicting Hematoma Growth And Outcome In Intracerebral Hemorrhage Using Contrast Bolus CT Scan

Sponsor: University of Calgary
Investigators: Carlos Kase MD (principal), Thanh Nguyen MD, Viken Babikian MD, Jose Romero MD, Aleksandra Pikula MD

Lancet Neurol. 2012 Apr;11(4):307-14
In patients with intracerebral haemorrhage (ICH), early haemorrhage expansion affects clinical outcome. Haemostatic treatment reduces haematoma expansion, but fails to improve clinical outcomes in many patients. Proper selection of patients at high risk for haematoma expansion seems crucial to improve outcomes. In this study, we aimed to prospectively validate the CT-angiography (CTA) spot sign for prediction of haematoma expansion.

PREDICT (predicting haematoma growth and outcome in intracerebral haemorrhage using contrast bolus CT) was a multicentre prospective observational cohort study. We recruited patients aged 18 years or older, with ICH smaller than 100 mL, and presenting at less than 6 h from symptom onset. Using two independent core laboratories, one neuroradiologist determined CTA spot-sign status, whereas another neurologist masked for clinical outcomes and imaging measured haematoma volumes by computerised planimetry. The primary outcome was haematoma expansion defined as absolute growth greater than 6 mL or a relative growth of more than 33% from initial CT to follow-up CT. We reported data using standard descriptive statistics stratified by the CTA spot sign. Mortality was assessed with Kaplan-Meier survival analysis. These findings confirm previous single-centre studies showing that the CTA spot sign is a predictor of haematoma expansion. The spot sign is recommended as an entry criterion for future trials of haemostatic therapy in patients with acute ICH.


IRIS: Insulin Resistance Intervention after Stroke Trial

Sponsor: NIH
Principal Investigator: Carlos Kase MD (principal), Thanh Nguyen MD, Viken Babikian MD, Jose Romero MD, Aleksandra Pikula MD

Summary: Pioglitazone is a medication that improves insulin resistance, and is approved by the FDA for diabetes. Insulin resistance is a condition in which insulin, a normal human hormone, does not work effectively because the body is resistant to its effects. Insulin resistance can lead to diabetes and is thought to cause blood vessel disease, including stroke and heart attack in patients with and without diabetes. This study is designed to find out if a diabetes medication, pioglitazone, helps prevent recurrent stroke or heart attack among patients who have recently had a stroke or TIA.

Study enrollment completion in July 2015 and results pending.


ATACH2: Antihypertensive Treatment of Acute Cerebral Hemorrhage

Sponsor: NIH
Investigators: Joseph Burns MD (principal), Jose Romero MD, Thanh Nguyen MD, Viken Babikian MD

Summary: Intracerebral hemorrhage, or "stroke caused by a bleed," is a fatal condition that often leads to disability and death. A common observation in this kind of stroke is that the bleed can grow in size with time. The growth of the bleed, which commonly occurs in the first 3-6 hours, can cause compression of the nearby structures in the brain leading to rapid deterioration of consciousness and death. Reducing blood pressure in the early stages of a hemorrhagic stroke is thought to limit the amount of brain damage that occurs. Less brain damage may reduce the high levels of death and disability commonly found in this form of stroke.

Purpose: Currently, there is insufficient evidence on what blood pressure levels are best for treating patients suffering from an intracerebral hemorrhage. The purpose of this study is to find out if there is a benefit to reducing systolic blood pressure (SBP) in a more intensive way (keeping SBP less than 140 mmHg) compared with standard SBP treatment (keeping SBP less than 180 mmHg). The primary way the study team will measure if intensive SBP treatment is better than standard SBP treatment is by assessing the disability levels of study participants three months after their stroke.

Results pending (study on-going)


MULTISTEM: Double-blind, Randomized, Placebo-controlled Phase 2 Safety and Efficacy Trial of MultiStem in Adults with Ischemic Stroke

Sponsor: Athersys
Investigators: Viken Babikian MD (principal), Jose Romero MD, Thanh Nguyen MD, Carlos Kase MD

Summary: Stem cells are the 'master cells' of the body from which other cells, tissues, organs, and bones are created. The two types of human stem cells are 'embryonic stem cells' that are created during the very early formation of a baby and 'adult stem cells' that are found in the tissues of all adults. MultiStem is an adult stem call product made up of living cells that came from one adult donor's bone marrow and his similar features to other blood products. This donor is anonymous, meaning that the donor's identity is unknown to you, the study doctor, or study staff. This donor was medically tested to ensure that he or she was healthy and did not have medical conditions that could be passed to you.

Purpose: A study to examine the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke. The hypothesis is that MultiStem will be safe and provide benefit following an ischemic stroke.

Results pending


MRRESCUE:A Trial of Imaging Selection and Endovascular Treatment for Ischemic Stroke

Sponsor: NIH
Investigators: Carlos Kase MD (principal), Viken Babikian MD, Thanh Nguyen MD, Jose Romero MD
CS. Kidwell, R Jahan, J Gornbein, JR Alger, V Nenov, Z Ajani, L Feng, BC Meyer, S Olson, LH Schwamm, AJ Yoo, RS Marshall, P M Meyers, DR Yavagal, M Wintermark, J Guzy, S Starkman, and JL Saver for the MR RESCUE Investigators
N Engl J Med 2013; 368:914-923 March 7, 2013 DOI: 10.1056/NEJMoa1212793

In this study, patients were randomly assigned within 8 hours after the onset of large-vessel, anterior-circulation strokes to undergo mechanical embolectomy (Merci Retriever or Penumbra System) or receive standard care. All patients underwent pretreatment computed tomography or magnetic resonance imaging of the brain. Randomization was stratified according to whether the patient had a favorable penumbral pattern (substantial salvageable tissue and small infarct core) or a nonpenumbral pattern (large core or small or absent penumbra). Outcomes were assessed using the 90-day modified Rankin scale, ranging from 0 (no symptoms) to 6 (dead).

In conclusion, a favorable penumbral pattern on neuroimaging did not identify patients who would differentially benefit from endovascular therapy for acute ischemic stroke, nor was embolectomy shown to be superior to standard care.

(Funded by the National Institute of Neurological Disorders and Stroke; MR RESCUE number, NCT00389467.)


CAA: A phase 2 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of Ponezumab in adult subjects with probable Cerebral Amyloid Angiopathy

Sponsor: Pfizer
Investigators: Carlos Kase MD (principal), Viken Babikian MD, Thanh Nguyen MD, Jose Romero MD, Hesham Masoud MD, Hugo Aparicio MD

Results pending.